ISO 9001 2000 Overview - Induction Sep07

ISO 9001:2000
Induction - Sep 2007
Protection notice / Copyright notice

Contents
What is ISO?
Definition of Quality
ISO 9001:2000 Model
Quality Management Principles
Quality Manual
Quality Audits

Page 2 Sep 2007 For Internal Use only P&Q
What is ISO?
International Organization for Standardization (ISO)
Is a worldwide federation of national standards bodies from some 130

countries, one from each country
Say what you do

Do what you say

What is ISO 9000?
 International standards for Quality Assurance

 Quality by focus on “process”
 Need for quality policy; standards and procedures
 Defines “whats” and not the “hows”
Focus on:
 Documented quality system covering all ISO
requirements
 Functioning in compliance to the documented quality
system

Definition of Quality
QUALITY is “FIT for USE
Customer’s perspective of Quality
QUALITY is “CONFORMANCE to
REQUIREMENTS”
Producer’s perspective of Quality

ISO 9000:2000 Model

YEAR 2000 STANDARDS
ISO Core standards

ISO 9000:2000 - Quality Management Systems –
Fundamentals and vocabulary
Requirements
Guidelines for performance improvements

The ISO 9001:2000 Model
Continual Improvement - Quality Management System

Benefits of a Process Model
Provides a structure to address all aspects of an Organization
Applies to any size or type of Organization
Directs Management attention to both people and products
Highlights process ownership and responsibility

PDCA Cycle & the Process Approach
Establish the
objectives and
processes
necessary to
Take actions to
deliver results in
continually
accordance with
improve process
customer
performance
requirements and
ACT PLAN
How to What to do?
the organization’s
improve next How to do it? policies
time?
CHECK
Did things DO
happen Do what was
Monitor and according to planned
measure processes plan? Implement the
and product against processes
policies, objectives
and requirements
for the product and Protection notice / Copyright notice
Page report
10 theSep
results
2007 For Internal Use only P&Q
Quality Management Principles

Eight Principles are used by senior management as a framework to guide
their organization towards improved performance. The ISO model is based
on these principles.
 Customer Focus
 Leadership
 Involvement of People
 The Process Approach
 A System approach to Management
 Continual Improvement
 Factual approach to decision making
 Mutually beneficial Supplier Relationship

• Focus on your customers
 Understanding customer needs and expectations
 Measuring customer satisfaction and acting on results
2 Provide leadership
 Being proactive and leading by example
 Establishing a clear vision of the organization’s future
3 Involve your people

 Accepting ownership and responsibility to solve problems
 Actively seeking opportunities to make improvements
4 Use a process approach

 Defining processes needed to achieve desired results
 Identifying and measuring inputs and outputs
 Evaluating risk and its impact Protection notice / Copyright notice
1 Take a systems approach
 Structuring the system in most efficient way.
 Understanding interdependencies of processes in the system
5 Encourage continual improvement

 Continual improvement of processes, systems and products
 Periodic assessment against established criteria
 Promoting prevention based activities
7. Get the facts before you decide

 Measuring and collecting data & Information
 Analyse data and information
 Make decisions and take actions based on analysis
8. Work with your suppliers

 Identifying and selecting key suppliers
 Establishing relationships that balance short term gains and long term
considerations
Compliance with ISO 9001:2000
Operate a Quality Management System that is:

Documented
Demonstrable
Effective
Maintained
Achieve certification and maintain it

Quiz
Q1 The PDCA cycle provides a framework for:
b) Improvement of software
c) improvement of a process or system
d) Improvement of testing cycle
Q2 The Quality Management Principle that creates a sense of belonging and pride to be
part of the organization is:
g) Customer Focused Organization
h) Process Approach
i) Involvement of People
Q3 The qualities of a good leader are:

l) Being proactive and leading by example
m) Establishing a clear vision of the organization’s future
n) Both the above
Quality Manual & Audits

The Quality Manual
The Quality Manual is :
 The superior document

 Contains a written description of your operational practices
 An explanation of how you comply with ISO 9000
 Represents ACTUAL practices of the registering unit
 Communicates policy
 Defines the organization and responsibilities
 Lists exceptions
 Provides a basis for assessment

SISL Quality Policy
SISL shall endeavour to deliver high

quality solutions and services to its
customers on time and in a consistent
manner. This shall be achieved through a
documented Quality Management System
that supports continual levels of
improvement across all business
processes. SISL shall ensure customer
delight by working and partnering closely
with them; while striving to develop
competencies and improve employee
satisfaction.

Internal Quality Audit
Ensures Quality Management System is maintained
Must be documented, demonstrable, effective, and maintained
Opportunity to assess system for opportunities for improvement
Required by ISO 9001 ( clause 8.2.2 )

Audit Objectives
 Add value
 Verify effectiveness of the implementation
 Establish the degree of compliance
 Identify areas for corrective action
 Find opportunities for continuous improvement
The findings are against project/process/function

and not against an individual

Audit Requirements
The audit must :
 Be described in the Quality Manual
 Follow a documented process
 Be done by trained auditors
 Be reviewed by senior management
 Feed directly into a Corrective Action Process
 Result in a written internal audit report

Corrective Action Process
The corrective action process should :
Be documented and approved
Be capable of eliminating deficiencies
Be used to evaluate the effectiveness of the quality management

system on a continual basis
Have wide ownership, rather then be owned by the quality department

alone
Have a clearly defined escalation process
Be accessible to all those who directly affect quality

Terminology
Correction
Action taken to eliminate a detected nonconformity
Corrective Action (Reactive)

Action taken to eliminate the cause of a detected
nonconformity or other undesirable situation
Preventive Action (Proactive)

Action taken to eliminate the cause of a potential
nonconformity or other potentially undesirable situation
Non Compliance
Minor non-compliance is an isolated non-fulfillment of a specific

requirement which has a negligible effect on quality i.e. it does not, on its
own indicate a breakdown in the QMS eg. Document numbering is not
as per project /quality plan.
Major non-compliance refers to a significant failure to comply with a

specified requirement or a breakdown of a quality system element
(which can be indicated by a pattern of minor non-compliance) eg. No. of
projects without a contract or review procedure in place, absence of a
project/quality plan.
Observation refers to a potential non-conformance or suggestion for

improvement
In case of any dispute Lead Auditor would moderate the findings

Quiz
Q4 Preventive Action is:
b) Proactive, where a cause of potential nonconformity is
removed
c) Reactive and done in fire-fighting mode
d) A corrective action on a defective software
Q5 The Internal Quality Audit aims at

g) Ensuring Quality Management System is maintained
h) QMS is documented, demonstrable and effective
i) Both the above
Q6 Quality is defined as :
l) Fitness for Use
m) Conformance to requirements
n) Both the above

Recap…
What is ISO?
Definition of Quality
ISO 9001:2000 Model
Quality Management Principles
Quality Manual
Quality Audits

Any Questions?

Thank You!


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ISO 9001:2000

Induction - Sep 2007

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ISO 9001:2000 Model

Quality Management Principles

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Is a worldwide federation of national standards bodies from some 130

Say what you do

Protection notice / Copyright notice

 International standards for Quality Assurance

Protection notice / Copyright notice

QUALITY is “FIT for USE

Customer’s perspective of Quality

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Protection notice / Copyright notice

ISO Core standards

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Continual Improvement - Quality Management System

Protection notice / Copyright notice

Provides a structure to address all aspects of an Organization

Applies to any size or type of Organization

Directs Management attention to both people and products

Highlights process ownership and responsibility

Protection notice / Copyright notice

Protection notice / Copyright notice

Protection notice / Copyright notice

3 Involve your people

4 Use a process approach

5 Encourage continual improvement

7. Get the facts before you decide

8. Work with your suppliers

Operate a Quality Management System that is:

Achieve certification and maintain it

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Q3 The qualities of a good leader are:

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The Quality Manual is :

 The superior document

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SISL shall endeavour to deliver high

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Must be documented, demonstrable, effective, and maintained

Opportunity to assess system for opportunities for improvement

Required by ISO 9001 ( clause 8.2.2 )

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 Verify effectiveness of the implementation

 Establish the degree of compliance

 Identify areas for corrective action

 Find opportunities for continuous improvement

The findings are against project/process/function

Protection notice / Copyright notice

The audit must :

 Be described in the Quality Manual

 Follow a documented process

 Be done by trained auditors

 Be reviewed by senior management

 Feed directly into a Corrective Action Process

 Result in a written internal audit report

Protection notice / Copyright notice

The corrective action process should :

Be documented and approved

Be capable of eliminating deficiencies